Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Hematopoietic Stem Cell Transplant Cope With Late Complications
Official Title
INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
Mar 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2008
Primary Completion Date
Nov 2011Actual
Completion Date
Not provided
First Submitted Date
Nov 26, 2008
First Submission Date that Met QC Criteria
Nov 26, 2008
First Posted Date
Nov 27, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 5, 2012
Last Update Posted Date
Mar 7, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: A personalized Internet-based program may help improve fatigue, depression, and quality of life in long-term survivors of stem cell transplant. It is not yet known whether an Internet-based program is more effective with or without telephone-based problem-solving training.
PURPOSE: This randomized clinical trial is studying how well an Internet-based program works with or without telephone-based problem-solving training in helping long-term survivors of hematopoietic stem cell transplant cope with late complications
Detailed Description
OBJECTIVES:
I. To determine the efficacy of a randomized controlled trial to improve long term fatigue/physical dysfunction, depression/distress and health surveillance behaviors in adult 3 to 25-year hematopoietic stem cell transplant (HSCT) survivors using an internet only or internet and phone-based problem-solving and activation training compared with survivors randomized to a delayed internet access control.
II. To determine the reach, utilization, and implementation costs of a web-based, individually tailored intervention, disseminated through widely used patient information websites, targeting a national cohort of adult 2-25 year HSCT survivors. (Phase III/IV) III. To determine, in a randomized controlled trial, the efficacy of a nationally disseminated, internet-based, individually tailored intervention to improve long-term fatigue, distress and health promotion behaviors in HSCT survivors, compared with survivors randomized to a delayed internet access control. (Phase III/IV)
OUTLINE: Patients with elevated fatigue, depression, and/or distress at baseline are randomized to 1 of 3 arms (ARMS I, II, or III). Patients without elevated fatigue, depression or distress at baseline are randomized to 1 of 2 arms (ARMS II or III).
ARM I (FULL WEBSITE ACCESS WITH PROBLEM-SOLVING TRAINING [PST]; FIRST STUDY ONLY; CLOSED TO ACCRUAL): Patients receive full access to INSPIRE website for 6 months, which offers an individually tailored greeting home page with links to information on each of the target areas identified as being elevated on baseline assessment and how to manage the complications; a bulletin board with input from other survivors that is solicited, edited, and posted weekly; resource pages; and an opportunity to send secure messages with questions or comments. Patients also undergo 4-8 phone-based PST sessions with a behavioral health specialist.
ARM II (FULL WEBSITE ACCESS WITHOUT PST): Patients receive full access to INSPIRE website for 6 months as in ARM I.
ARM III (DELAYED WEBSITE ACCESS): Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.
Conditions Module
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Psychosocial Effects of Cancer and Its Treatment
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,337Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I (full website access w/ PST; first study only)
Experimental
Patients receive full access to INSPIRE website for 6 months, which offers an individually tailored greeting home page with links to information on each of the target areas identified as being elevated on baseline assessment and how to manage the complications; a bulletin board with input from other survivors that is solicited, edited, and posted weekly; resource pages; and an opportunity to send secure messages with questions or comments. Patients also undergo 4-8 phone-based PST sessions with a behavioral health specialist.
Other: internet-based intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: assessment of therapy complications
Procedure: management of therapy complications
Procedure: fatigue assessment and management
Other: counseling intervention
Arm II (full website access without PST)
Experimental
Patients receive full access to INSPIRE website for 6 months as in arm I.
Other: internet-based intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: assessment of therapy complications
Procedure: management of therapy complications
Procedure: fatigue assessment and management
Arm III (delayed website access)
Sham Comparator
Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.
Other: internet-based intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care
Interventions
Name
Type
Description
Arm Group Labels
Other Names
internet-based intervention
Other
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
Arm I (full website access w/ PST; first study only)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Aggregate number of targeted problems
At 6 months
Reach of web-based intervention (second, phase III/IV study only)
As indicated by proportion logging on the website content for males (targeting 50%), older (targeting 50% over age 55), and geographically underserved participants (targeting 20% rural residents as indicated by zip code), as well as percent who logon to the study website content after initially registering for the study (targeting 90%) second
At 6 months
Utilization of web-based intervention (second, phase III/IV study only)
As indicated by number of pages viewed (targeting a mean of 10), log-on times (targeting a mean of 2) and time from notification of website content access to website content logon (targeting a mean of 2 weeks)
At 6 months
Satisfaction, use and barriers ratings at the end of the study including barriers to website use and barriers to using health promotion guidelines (second, phase III/IV study only)
At 6 months
Cost to maintain the site content (not including costs for maintenance of the assessment process) (second, phase III/IV study only)
As indicated by per participant prorated costs for materials and time for updating content, responding to participant comments and requests, maintaining programming and responding to technical problems
At 6 months
Secondary Outcomes
Measure
Description
Time Frame
Mean z score combining the Vitality and Physical Function subscales of the SF-36
At 6 months
Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress - Uncertainty subscale
At 6 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Hematopoietic stem cell transplant recipient between 3-25 years since last transplant
Hematopoietic stem cell transplant recipient > = 2 years since last transplant (second, phase III/IV study only)
Any type of transplant (autologous, allogeneic, myeloablative, non-myeloablative, marrow or peripheral blood stem cells)
Able to communicate in English as indicated by ability to communicate adequately with study staff to participate in the clinical phone calls and to complete patient-reported outcomes (PRO) assessments in English
Has internet and email access (indicated by logon to site for consent and assessment)
Exclusion Criteria:
Does not complete the baseline assessment through the HADS (Hospital Anxiety and Depression Scale)
Does not complete required assessments in the background and medical history forms required to determine whether meet inclusion and exclusion criteria, stratification, sample description, or primary outcomes (includes age, gender, ethnicity, race, transplant site, and medical information about transplant if not FHCRC or SCCA patient, education, work, height and weight, current medications
Survivors who score 3.0 or above on the SCL depression measure (indicating severe depression) or who report moderate to severe suicidal ideation will be ineligible for randomization; these survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
Survivors who report to us that they have been in active treatment for relapse of their original disease, or for a second cancer, in the past 2 years will be ineligible for randomization, unless the second cancer was treated only with surgical removal (e.g., basal, squamous or localized melanoma skin cancer, or breast ductal carcinoma in situ [DCIS])
These survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Karen Syrjala
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Walsh CA, Yi JC, Leisenring WM, Syrjala KL. Social Support, Coping, and Cancer-Related Health Burden in Long-term Survivors Treated with Hematopoietic Stem Cell Transplantation as Adolescents or Young Adults. J Adolesc Young Adult Oncol. 2023 Aug;12(4):496-502. doi: 10.1089/jayao.2022.0105. Epub 2022 Oct 25.
Norskov KH, Yi JC, Crouch ML, Fiscalini AS, Flowers MED, Syrjala KL. Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors. J Cancer Surviv. 2021 Dec;15(6):866-875. doi: 10.1007/s11764-020-00979-4. Epub 2021 Jan 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Refractory Multiple Myeloma
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Small Lymphocytic Lymphoma
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Not provided
Procedure: assessment of therapy complications
Procedure: management of therapy complications
Procedure: fatigue assessment and management
Arm II (full website access without PST)
Arm III (delayed website access)
questionnaire administration
Other
Completion of questions in an online format
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
psychosocial assessment and care
Procedure
Assessment and care of psychosocial aspects
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
psychosocial assessment
psychosocial assessment/care
psychosocial care
psychosocial care/assessment
psychosocial studies
assessment of therapy complications
Procedure
Evaluation of complications of treatment
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
management of therapy complications
Procedure
Managing therapy complications
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
complications of therapy, management of
fatigue assessment and management
Procedure
Assessing and managing fatigue
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
fatigue assessment/management
counseling intervention
Other
Counseling provided via telephone
Arm I (full website access w/ PST; first study only)
counseling and communications studies
Total health care utilization behaviors
At 6 months
Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only)
At 6 months
Long-term health promotion of survivors compared with controls (second, phase III/IV study only)
Walsh CA, Yi JC, Rosenberg AR, Crouch MV, Leisenring WM, Syrjala KL. Factors associated with social functioning among long-term cancer survivors treated with hematopoietic stem cell transplantation as adolescents or young adults. Psychooncology. 2020 Oct;29(10):1579-1586. doi: 10.1002/pon.5460. Epub 2020 Aug 13.